Summa Therapeutics recalled 22 units of the Finesse BTK Multicath Injectable Angioplasty Balloon Catheter sold to healthcare facilities in New Jersey and Florida. The balloon may not meet burst specifications, raising risk during angioplasty. Healthcare providers must stop using the device immediately and follow recall instructions from Summa Therapeutics.
Potential for the balloon in the device to not meet burst specifications.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact SUMMA THERAPEUTICS, LLC or your healthcare provider for instructions. Notification method: Letter
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This is an over-the-wire injectable angioplasty balloon catheter used in cardiovascular interventions. It features a 2.5mm balloon diameter, 225mm balloon length, and a 150cm working length, with a 5 French sheath and 0.014" guidewire compatibility.
A balloon not meeting burst specifications can fail during inflation, potentially causing vessel injury or other complications requiring further intervention.
This recall is not presented as part of a broader industry pattern.
Hospitals and clinicians may need to pause procedures using this device pending replacement or refunds. The issue could cause procedure delays and additional costs for health facilities.
Recall letter and FDA enforcement report provide identification details and remedy steps.
Remedies, including refunds or replacements, are expected to follow recall processing timelines typical for medical-device recalls (not specified in a
Keep the recall letter, original packaging, labeling, and all correspondence with Summa Therapeutics; document lot numbers and device IDs for future audits.
Model/Catalog Number: FS252251502; UDI-DI: 00810017490967; Lots: 240502, 240095, 231296, 231296A, 240095A. Sold to facilities in New Jersey and Florida. Sold date: Unknown. Price: Unknown. Quantity: 22 units. Recall date: 2025-07-21. Status: ACTIVE. Distributor: Summa Therapeutics.
No injuries or incidents have been reported.
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